DUMIROX 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dumirox 100 mg Film-Coated Tablets

fluvoxamine maleate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What is Dumirox and what is it used for
2. Before you take Dumirox
3. How to take Dumirox
4. Possible side effects
5. Storage of Dumirox
6. Contents of the pack and other information

1. What is Dumirox and what is it used for

The active substance of Dumirox is fluvoxamine; it belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It is an antidepressant and is used to treat depression (major depressive disorder).

Dumirox can also be used to treat people who suffer from obsessive-compulsive disorder (OCD)

2. Before you take Dumirox

Do not take Dumirox:

• if you are allergic (hypersensitive) to fluvoxamine or any of the other ingredients of Dumirox (see section 6 "Further information")
• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs) sometimes prescribed for depression or anxiety, including linezolid (an antibiotic that is also an MAOI).

Treatment with fluvoxamine should be started at least 2 weeks after you have stopped taking an irreversible MAOI. However, treatment with fluvoxamine after stopping certain reversible MAOIs can be started the next day. In exceptional cases, linezolid (an antibiotic MAOI) may be used with fluvoxamine if your doctor closely supervises you.

Your doctor will advise you how to take Dumirox once you have stopped taking MAOIs

• if you are taking tizanidine, a medicine used as a muscle relaxant
• if you are breast-feeding
• if you are taking pimozide, an antipsychotic medicine used in the treatment of schizophrenia and other psychiatric disorders

If any of the above applies to you, do not takeDumirox and consult your doctor

Warnings and precautions

Consult your doctor or pharmacist beforetaking the medicine:

• if you have recently had a heart attack
• if you are pregnant, or think you might be pregnant
• if you have epilepsy
• if you have a history of bleeding problems or if you regularly take medicines that increase the risk of bleeding, such as painkillers, or if you are pregnant (see "Pregnancy" below)
• if you have diabetes
• if you are undergoing electroconvulsive therapy (ECT)
• if you have a history of having suffered from mania (feeling of euphoria or overexcitement)
• if you have liver or kidney problems
• if you have high blood pressure (glaucoma)
• if you are under 18 years old (see also section 3 "How to take Dumirox")
• if you are taking medicines containing opioids such as buprenorphine or buprenorphine/naloxone, as these products taken in combination with Dumirox can cause serotonin syndrome, a potentially life-threatening condition (for symptoms, see section 4 "Possible side effects") and "Other medicines and Dumirox".

If any of the above applies to you, your doctor will indicate if it is safe for you to start treatment with Dumirox.

Occasionally, ideas of agitationmay occur, you cannot sit or stay still (akathisia) in the first weeks of treatment with Dumirox, until the antidepressant effect occurs.

Inform your doctor immediately if you have these symptoms. It may be helpful to adjust the dose.

Severe skin reactions have been reported when using Dumirox. Stop takingDumirox and contact your doctor immediately if you develop a rash or lesions on the mucous membranes. Severe rashes can include rash that starts on the extremities, usually on both sides of the body and evolving into concentric circles that resemble erythema (erythema multiforme), widespread rash with blisters and peeling of the skin, which occurs particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis).

Medicines like Dumirox (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. This may increase when you first start taking antidepressant treatment, as these medicines take time to work, usually about two weeks, but sometimes longer.

You are more likely to think this way if:

• you have previously had thoughts of suicide or self-harm.
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

If you have thoughts of self-harm or suicide, tell your doctor or go directly to a hospital.

It may be helpful to tell a relative or friendthat you are feeling depressed or have an anxiety disorder, and ask them to read this leaflet. You can ask them their opinion on whether you are getting worse, or if they are worried about the changes in your behavior.

Tell your doctor immediatelyif you have thoughts or experiences that distress you.

Use in children and adolescents under 18 years

Children and adolescents under 18 years should not take this medicine, unless they are being treated for obsessive-compulsive disorder (OCD). This is because Dumirox is not used to treat depression in people under 18 years.

When taking this type of medicine, patients under 18 years have a higher risk of side effects such as attempted suicide, suicidal thoughts, and hostility, such as aggression, confrontational behavior, and irritability.

If your doctor has prescribed Dumirox to a patient under 18 years for a condition other than obsessive-compulsive disorder and you want to discuss this decision, go back to your doctor.

If a patient under 18 years is taking Dumirox, they must tell their doctor if any of the symptoms mentioned above get worse or if they have complications.

There is no information on the long-term safety of Dumirox in people under 18 years regarding growth, maturity, and intellectual and behavioral development.

Use of other medicines

• do not start taking the herbal remedy "St. John's Wort" if you have been prescribed Dumirox, as it may increase the risk of side effects. If you are already taking "St. John's Wort" when you start treatment with Dumirox, stop taking "St. John's Wort" and consult your doctor at your next visit.

Your doctor or pharmacist should know if you are taking other medicines for depression or related psychiatric conditions, which contain:

• benzodiazepines
• tricyclic antidepressants
• neuroleptics or antipsychotics
• lithium
• tryptophan
• monoamine oxidase inhibitors (MAOIs) such as moclobemide
• pimozide
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram

Your doctor will tell you if it is safe for you to start treatment with Dumirox.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• aspirin (acetylsalicylic acid) or similar medicines used to treat pain and inflammation (arthritis)
• cyclosporin, used to reduce the activity of the immune system
• methadone, used to treat pain and withdrawal syndrome
• mexiletine, used to treat heart rhythm disorders
• phenytoin or carbamazepine, used to treat epilepsy
• propranolol, used to treat high blood pressure and heart disorders
• ropinirole, for Parkinson's disease
• a "triptan", used to treat migraines, such as sumatriptan
• terfenadine, used to treat allergies. Dumirox should not be used with terfenadine
• sildenafil, used in the treatment of erectile dysfunction
• theophylline, used to treat asthma and bronchitis

-tramadol (painkillers)

• buprenorphine or buprenorphine/naloxone
• clopidogrel, warfarin, acenocoumarol, or any anticoagulant medicine

If you are taking or have recently taken any of the medicines listed above and have not told your doctor, go back to your doctor and ask what you should do. Your doctor may change your dose or may need to give you a different medicine.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This also includes herbal remedies.

Taking Dumirox with food and drink

• do not drink alcohol if you are taking this medicine. Alcohol may interact with Dumirox and cause drowsiness and instability.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

There is only limited experience with the use of fluvoxamine during pregnancy. Do not take Dumirox if you are pregnant unless your doctor considers it absolutely necessary. If you are currently taking fluvoxamine and are planning to become pregnant, please consult your doctor to see if it is necessary or appropriate to change your medication.

Animal studies have shown that fluvoxamine reduces sperm quality. This could theoretically affect fertility, but so far, no impact on human fertility has been observed.

Make sure your midwife and/or doctor know that you are being treated with fluvoxamine. If you take it during pregnancy, especially in the last 3 months, medicines like fluvoxamine may increase the risk of a serious condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should inform your midwife and/or doctor immediately.

Do not stop treatment with fluvoxamine suddenly. If you have been taking fluvoxamine during the last 3 months of pregnancy, your baby may have other symptoms at birth, in addition to difficulty breathing or blue skin, such as not being able to sleep or feed properly, being too hot or cold, feeling unwell, crying a lot, stiff or floppy muscles, lethargy, drowsiness, tremors, or becoming nervous or having seizures. If your baby has any of these symptoms at birth, consult your doctor immediately.

If you take Dumirox in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Dumirox to advise you.

Breast-feeding

Fluvoxamine passes into breast milk. There is a risk that it may affect the newborn. Therefore, you should discuss with your doctor who will decide whether you should stop breast-feeding or stop treatment with fluvoxamine.

Driving and using machines

During treatment with Dumirox 100, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how the treatment with Dumirox 100 affects you.

Dumirox contains sodiumThis medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Dumirox

How much Dumirox to take

Always take the amount of Dumirox that your doctor has prescribed.

If you are not sure, consult your doctor or pharmacist.

Normal initial dose for adults (from 18 years):

Treatment of depression:

• Start with 50 or 100 mg per day, taken at night.

Treatment of obsessive-compulsive disorder:

• Start with 50 mg per day, preferably at night.

If you do not start to feel better after a couple of weeks, inform your doctor, who will advise you. Your doctor will indicate how to gradually increase the dose.

The highest recommended daily dose is 300 mg.

If your doctor advises you to take more than 150 mg per day, do not takethe entire dose at once; ask your doctor when to take each dose.

Normal dose for children and adolescents with obsessive-compulsive disorder - OCD (from 8 years):

Start with 25 mg (half a tablet) per day, preferably at bedtime. Your doctor may increase the dose every 4-7 days in increments of 25 mg if tolerated until an effective dose is reached.

The highest recommended daily dose is 200 mg.

If your doctor advises you to take more than 50 mg per day, do not takethe entire dose at once; ask your doctor when to take each dose. If the dose cannot be divided into equal parts, the highest dose should be taken at night.

Children and adolescents under 18 years should not takethis medicine for the treatment of depression. This medicine should onlybe prescribed for children and adolescents in the case of obsessive-compulsive disorder (OCD).

How to take Dumirox

Swallow the tablets with water. Do notchew them.

You can split the tablets in half if your doctor advises you to do so.

When it takes effect

Dumirox takes some time to work. Some patients do not feel better during the first 2 or 3 weeks of treatment.

Take thetablets until your doctor tells you to stop.

Even if you feel better, your doctor may advise you to continue taking the tablets for some time, at least six months, to ensure that the medicine has taken full effect.

Do not stoptreatment with Dumirox abruptly.

You may experience withdrawal symptomssuch as:

• agitation and anxiety
• confusion
• diarrhea
• difficulty sleeping/intense dreams
• dizziness
• emotional instability
• headache
• irritability
• nausea and/or vomiting
• palpitations (faster heartbeats)
• sensory disturbances (such as electric shock sensations or visual disturbances)
• sweating
• tremors

To stop treatment with Dumirox, your doctor will indicate that you should gradually reduce the dose over a number of weeks or months, which will help reduce the incidence of withdrawal effects. Most people find that the symptoms when stopping treatment with Dumirox are mild and stop during the two weeks following. For some people, these symptoms can be more severe or can last longer.

If you experience withdrawal symptoms when you stop treatment, consult yourdoctor.

If you take more Dumirox than you should

If you or someone else has taken more Dumirox than they should (an overdose), inform your doctor, go directly to a hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Take the medicine package with you.

The symptoms of overdose include, but are not limited to, nausea, vomiting, diarrhea, and feeling drowsy or dizzy. Cardiac symptoms (slow or fast heart rate, low blood pressure), liver complications, seizures (attacks), and coma have been reported.

If you forget to take Dumirox

If you forget to take a tablet, wait until the next dose. Do not take a double dose to make up for the forgotten doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Dumirox can cause adverse effects, although not all people suffer from them. The frequencies of the observed adverse effects are defined as described below:

Adverse Effects Related to this Type of Medication

Occasionally, suicidal thoughts or self-harmmay occur or increase during the first weeks of treatment with Dumirox, until the antidepressant effect occurs.

Inform your doctor immediatelyif you have distressing thoughts or experiences.

If you have several symptoms at the same time, it may be that you have one of the rare conditions described below:

• Serotonin syndrome: If you have sweating, muscle stiffness or spasms, instability, confusion, irritability, or extreme agitation.
• Neuroleptic malignant syndrome: If you have muscle stiffness, fever, confusion, and other related symptoms.
• SIADH: if you feel tired, weak, or confused and have painful, numb, or uncontrolled muscles.
• Severe skin reactions, such as severe skin rash or redness, including generalized rash, which starts on the extremities on both sides of the body and evolves into concentric circles resembling erythema (erythema multiforme), generalized skin rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of the body surface - toxic epidermal necrolysis). The frequency of these side effects is unknown (cannot be estimated from the available data).

Stoptaking Dumirox and consult your doctor immediately.

If you notice unusual bruises or purple spots on your skin or if you vomit blood or have blood in your stool, contact your doctor.

Stopping fluvoxamine (especially when done abruptly) often leads to withdrawal symptoms (see section 3 withdrawal symptoms).

Sometimes patients experience nauseawhen starting treatment with Dumirox and it starts to take effect. Although the feeling of nausea is unpleasant, it should pass soon if you continue taking the tablets as prescribed. This may occur within a few weeks.

Adverse Effects Caused by Dumirox

Common Adverse Effects:

• agitation
• anxiety
• constipation
• diarrhea
• difficulty sleeping
• dizziness
• dry mouth
• faster heart rate
• sleepiness (lethargy)
• malaise
• headache
• indigestion
• loss of appetite
• nervousness
• stomach pain
• sweating
• tremor
• muscle weakness (asthenia)
• vomiting

Uncommon Adverse Effects:

• allergic skin reactions (including facial sweating, lip or tongue swelling, rash, or itching)
• confusion
• delayed ejaculation
• dizziness when standing up too quickly
• hallucinations
• lack of coordination
• muscle or joint pain
• aggression

Rare Adverse Effects:

• seizures
• liver disorders
• mania (feeling of hyperexcitement)
• photosensitivity
• unexpected milk flow

Very Rare Adverse Effects:

• akathisia (agitation)
• abnormal taste
• anorgasmia (inability to reach orgasm)
• in women: menstrual disorders (monthly bleeding)
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information
• urination disorders (such as frequent need to urinate during the day and/or night, sudden loss of urinary control during the day and/or night, or lack of urinary ability)
• paresthesia (tingling or numbness)
• increased prolactin (a hormone that stimulates milk production in breastfeeding mothers)
• dilated pupils
• changes in body weight
• glaucoma (increased eye pressure)

An increased risk of bone fractures has been observed in patients taking this type of medication.

Unknown Frequency

• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Adverse Effects Related to the Treatment of OCD in Children and Adolescents, No Frequencies are Given

• hypomania (feeling of euphoria and overexcitement)
• agitation
• seizures
• difficulty sleeping (insomnia)
• lack of energy (asthenia)
• hyperactivity (hyperkinesia)
• feeling of sleepiness
• indigestion

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dumirox

Keep out of the reach and sight of children.

• Do not use the tablets after the expiration date shown on the box after "CAD" or "EXP". The expiration date is the last day of the month indicated.
• Do not store above 25°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dumirox

The active ingredient is fluvoxamine maleate.

Each tablet contains 100 mg of fluvoxamine as maleate.

The other ingredients are mannitol (E421), cornstarch without gluten, pregelatinized starch, sodium stearyl fumarate, anhydrous colloidal silica, hypromellose, macrogol 6000, talc, and titanium dioxide (E171).

Appearance of the Product and Package Contents

Dumirox 100 mg is presented in the form of film-coated tablets, white or almost white, oval, and with a mark "313" on the 2 sides separated by the dividing line.

Dumirox 100 mg is available in packages of 15, 20, 30, 50, 60, 90, 100, 120, and 250 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

01400 Châtillon-sur-Chalaronne

France

or

Recipharm Parets, S.L.U.

C/ Ramón y Cajal, 2

08150 - Parets del Vallés (Barcelona)

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This pharmaceutical product is authorized in the Member States of the EEA under the following names:

Austria Floxyfral

Belgium Floxyfral

France Floxyfral

Germany Fevarin

Greece Dumyrox

Ireland Faverin

Italy Dumirox

Luxembourg Floxyfral

Norway Fevarin

Portugal Dumyrox

Spain Dumirox

Sweden Fevarin

Netherlands Fevarin

United Kingdom (NI) Faverin

Date of Last Revision of this Prospectus:April 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.es//